RED-FLAGS Index Validation in Crohn's Disease Patients

NCT02940054 | Unknown

• 1 other identifier: 1414
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Observational prospective study to validate a new index for early diagnosis of Crohn's disease (CD)

Conditions

Crohn's Disease

Keywords

Early diagnosis

Outcome Measures

Primary Outcomes (1)

• Sensibility of the Red Flags Index

  Sensibility, specificity, accuracy, positive and negative likelihood ratio measurement

  at enrollment

Secondary Outcomes (2)

• Percentage of early diagnosed

  6 months of prospective period

• Cut-off for Crohn's disease diagnosis

  at enrollment

Study Arms (1)

Patents with suspected Crohn's disease

Adult patients showing at least one of the following symptoms, from at least 4 weeks: * diarrhea * nocturnal diarrhea * body weight loss (\>5%) * abdominal pain * perianal lesions.

Other: Red-flags questionnaire

Interventions

Red-flags questionnaire OTHER

A questionnaire composed by 8 items will be administered by GPs to those patients and they will be referred to a gastroenterologist with expertise in CD. All those patients will be evaluated, as per usual practice, to confirm or exclude Crohn's disease.

Patents with suspected Crohn's disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

600 subjects, aged 18-65, requiring general practitioner's advise for gastrointestinal symptoms compatible with Crohn's disease.

You may qualify if:

• at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent)
• diarrhea (\>3 bowel movements per day)
• nocturnal diarrhea
• weight loss (≥5% of usual body weight)
• abdominal pain (chronic or intermittent)
• perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded)
• In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

You may not qualify if:

• known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease
• any clinical condition that, in the opinion of the investigator, can alter stud results
• inability to understanding and complying with protocol requirements
• informed consent not signed and dated by the subject

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Takeda: collaborator
• IG-IBD talian Group for Inflammatory Bowel Diseases: collaborator

Study Sites (1)

Humanitas Gavazzeni

Bergamo, BG, Italy

RECRUITING

Related Publications (1)

• Danese S, Fiorino G, Mary JY, Lakatos PL, D'Haens G, Moja L, D'Hoore A, Panes J, Reinisch W, Sandborn WJ, Travis SP, Vermeire S, Peyrin-Biroulet L, Colombel JF. Development of Red Flags Index for Early Referral of Adults with Symptoms and Signs Suggestive of Crohn's Disease: An IOIBD Initiative. J Crohns Colitis. 2015 Aug;9(8):601-6. doi: 10.1093/ecco-jcc/jjv067. Epub 2015 Apr 23.

  PMID: 25908718 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Silvio Danese, MD, PhD

CONTACT

IBDclinicaltrials@humanitas.it

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 20, 2016
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 24, 2016

Record last verified: 2016-10

Locations

IT (1)